Pre-evaluation of virology EQASs March 2017 Virology March... · Pre-evaluation Virology March 2017...

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Pre-evaluation Virology March 2017 20170512.doc 1 of 15 Pre-evaluation of the External Quality Assessment Schemes in Virus Diagnostics March 2017 Prof. Dr. Heinz Zeichhardt Dr. Martin Kammel Issued by: INSTAND Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e.V. Düsseldorf/Berlin, Germany, 12.05.2017

Transcript of Pre-evaluation of virology EQASs March 2017 Virology March... · Pre-evaluation Virology March 2017...

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Pre-evaluation of the External Quality Assessment Schemes in Virus Diagnostics

March

2017

Prof. Dr. Heinz Zeichhardt

Dr. Martin Kammel

Issued by:

INSTAND

Gesellschaft zur Förderung

der Qualitätssicherung

in medizinischen Laboratorien e.V.

Düsseldorf/Berlin, Germany, 12.05.2017

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INSTAND EQA Schemes in Virus Diagnostics in cooperation with:

Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten e.V. (DVV)

Gesellschaft für Virologie e.V. (GfV)

Deutsche Gesellschaft für Hygiene und Mikrobiologie e.V. (DGHM)

EQAS Adviser: Assistant EQAS Adviser: Prof. i. R. Dr. Heinz Zeichhardt Dr. Martin Kammel Charité - University Medicine Berlin c/o INSTAND e.V. Ubierstr. 20, 40223 Düsseldorf Correspondence address: Tel.: +49-(0)30-81054-300; Fax: +49-(0)30-81054-303 Prof. Dr. Heinz Zeichhardt Email: [email protected]

Institut für Qualitätssicherung in der Virusdiagnostik - IQVD Potsdamer Chaussee 80, D-14129 Berlin, Germany Tel.: +49-(0)30-81054-300; Fax: +49-(0)30-81054-303 Email: [email protected]

Organisation and Logistics:

INSTAND e.V. Ubierstr. 20 D-40223 Düsseldorf, Germany Tel.: +49 (0)211 - 1592 13 0 Fax: +49 (0)211 - 1592 1330 Email: [email protected] Internet: www.instand-ev.de

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Pre-Evaluation

and Mailing of Participation Documents

INSTAND External Quality Assessment Schemes – March 2017

Virus Immunology Virus Genome Detection by PCR/NAT

Dear colleagues,

You have participated in one or several of the INSTAND external quality assessment (EQA) schemes in virus diagnostics of March 2017. Today you receive the pre-evaluation.

By mail, you receive the following participation documents of those EQA schemes in which you have participated this time:

certificate of successful participation statement of participation statement of individual results

The EQA schemes having been performed in March 2017 are highlighted in bold in Tables 1 and 2. For these highlighted EQA schemes, the corresponding participation documents will be sent out by mail together with this pre-evaluation. Please note: The below mentioned INSTAND EQA schemes were postponed to the second quarter of 2017 in order to consider new circulating virus variants for the corresponding panel (shipment date: 08 May 2017):

Influenza viruses (genome / Ag) (370)

Norovirus (381)

Table 1: EQA schemes performed with a frequency of four times per year

VIRUS IMMUNOLOGY:

Cytomegalovirus (351) Hepatitis A virus (343) Hepatitis B virus Prog. 1 (344) Hepatitis B virus Prog. 2 (345) Hepatitis C virus (346) HIV-1/HIV-2 (335) HIV-1 p24 Ag (337)

VIRUS GENOME DETECTION:

Cytomegalovirus (365) Hepatitis A virus (377) Hepatitis B virus (361) Hepatitis C virus (362) HIV-1 (RNA) (360) Parvovirus B19 (367)

The EQA schemes having been performed in March 2017 are highlighted in bold (Table 1). For these highlighted EQA schemes, the corresponding participation documents will be sent out by mail together with this pre-evaluation.

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Table 2: EQA schemes performed twice per year or with lower frequency (EQA schemes having been performed in March 2017 are highlighted in bold)

VIRUS IMMUNOLOGY:

Chikungunya virus (402) Dengue viruses (Ab/NS1-Ag) (350) Epstein Barr virus (352) TBE (FSME) virus (358) Hantaviruses (355) Hepatitis D virus (347) Hepatitis E virus (348) Herpes simplex viruses (354) HTLV-1/HTLV-2 (339) Measles virus (357) Mumps virus (356) Parvovirus B19 (342) Rubella virus (341) Rabies (Tollwut) virus (336) Varicella zoster virus (353) Zika virus (338)

VIRUS GENOME DETECTION:

Adenoviruses (371) BK virus (364) Chikungunya virus (392) Coronaviruses (340) Cytomegalovirus training program (368) Cytomegalovirus resistance determination (349) Dengue viruses (369) Enteroviruses (372) RKI-Entero-Surveillance (every two years) (374) Epstein Barr virus (376) Hepatitis B virus training program (378) Hepatitis B virus genotyping (396) Hepatitis B virus resistance determination (397) Hepatitis C virus training program (379) Hepatitis C virus geno-/subtyping (375) Hepatitis C virus resistance determination (399) Hepatitis D virus (400) Hepatitis E virus (380) Herpes simplex virus type 1/2 (363) HIV-1 (RNA) training program (382) HIV-1 drug resistance determ. (standard progr.) (383) HIV-1 drug resistance determ. (additional progr.) (384) HIV-2 (RNA) (395) Human Metapneumovirus (385) Human Papilloma viruses (373) Human Rhinoviruses (393) Influenza viruses (genome/Ag) (370)* JC virus (394) Measles virus (386) Mumps virus (387) Norovirus (381)* Parainfluenza viruses (388) Respiratory syncytial virus (Ag/genome) (359) Rotaviruses (401) Rubella virus (389) Rabies (Tollwut) virus (390) Varicella zoster virus (366) West Nile virus (391) Zika virus (403)

* The INSTAND EQA schemes Influenza viruses (genome / Ag) (370) and Norovirus (381) were postponed to the second quarter of 2017 in order to consider new circulating virus variants for the corresponding panel (shipment date: 08 May 2017).

The EQA schemes having been performed in March 2017 are highlighted in bold (Table 2). For these highlighted EQA schemes, the corresponding participation documents will be sent out by mail together with

EQA schemes in Table 2 marked in italics were not performed in March 2017.

Please see the following Tables 3, 4 and 5 for details on sample properties and the expected target values for this EQA scheme March 2017. You received information on sample properties already per email on 18.04.2017.

The reports of all EQA schemes will be released on the INSTAND homepage immediately after completion. For details please see the INSTAND homepage under "EQAS Online / Service for EQA tests / EQA area (Virus immunology / Virus genome detection)" in English language: http://www.instand-ev.de/en/eqas-online/service-for-eqa-tests.html and in German language: http://www.instand-ev.de/ringversuche-online/ringversuche-service.html.

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Please note:

RiliBÄK A compilation of the "Guidelines of the German Medical Association on quality assurance in medical laboratory testing (Bundesärztekammer / RiliBÄK = Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen)" with all Sections including Section B 2 "Qualitative medical laboratory testing = Qualitative laboratoriumsmedizinische Untersuchungen" and Section B 3 "Direct detection and characterisation of infectious agents = Direkter Nachweis und Charakterisierung von Infektionserregern" has recently been published (in German language: Deutsches Ärzteblatt, Jg. 111, Heft 38, 19. September 2014, A 1583 - A 1618) (please see link).

An English version of the guideline translated by INSTAND e.V. with the consent of the Executive Board of the German Medical Association has been published in "German Medical Science" [in English language: Bundesärztekammer (German Medical Association), Instand e.V., Guidelines of the German Medical Association on quality assurance in medical laboratory testing. GMS Z Forder Qualitatssich Med Lab. 2015; 6] (please see link).

Notice for German laboratories: The requirements laid down in Specified Section B 3 - effective since 01.04.2013 and with a transition period until 31.05.2015 - should now be fulfilled.

INSTAND EQA schemes in virus diagnostics and INSTAND ordering documents 2017 For details please see the INSTAND ordering documents 2017 incl. brochure and order form (please see link).

Additional training programs in virus genome detection

Additional training programs were provided for the sixth time with the EQAS term March 2017.

Cytomegalovirus (368) Hepatitis B virus (378) Hepatitis C virus (379) HIV-1 (RNA) (382)

Please note: Additional training programs for virus genome detection of CMV, HBV, HCV and HIV-1 (RNA), respectively, containing low virus concentrations, are offered once only in March. The integration of the previous EQA scheme terms (March and September) will make it possible to evaluate a larger number of analyses with improved statistics.

A training program contains low-concentration samples for each of the viruses to verify test sensitivities. The low-concentration samples are used as a complement to the respective main EQA scheme and contain samples with virus concentrations within the requirements of the new Guidelines of the German Medical Association on quality assurance in medical laboratory testing (Bundesärztekammer/RiliBÄK = Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen) as specified in Table B 3-2a of the RiliBÄK.

Please note: A training program can only be ordered together with the corresponding main EQA scheme in March 2018.

Separate certificates will be issued for each main EQA scheme (subject to RiliBÄK-B 3) and training program.

Surplus samples of the current and previous EQA schemes in virus diagnostics are available for test assessment of your virus diagnostics. Please contact INSTAND e.V. for details.

Thank you for your kind cooperation. Prof. Dr. H. Zeichhardt Dr. M. Kammel

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Table 3: EQA Schemes Virus Immunology - March 2017 Pre-evaluation

Program Group RiliBÄK Analyte Sample Sample properties

qualitative dilution sample source

Cyto-megalo-

virus (Ab)

serum

351

conform to

B 2

anti-CMV-IgG anti-CMV-IgM

351055 positive avidity: high negative

past CMV infection (two healthy blood donors)

anti-CMV-IgG anti-CMV-IgM

351056 positive avidity: high negative

past CMV infection (two healthy blood donors)

Dengue-viruses*

(Ab and

NS1-Ag)

serum

350*

anti-Dengue

conform to

B 2

NS 1 Ag

conform to

B 3

anti-Dengue-IgG anti-Dengue-IgM Dengue NS1-Ag

350054

positive not evaluated negative

sample 350054 and sample 350055 derive from the same patient D25

sample 350054 is a follow-up serum of patient D25

sample 350054 represents a primary dengue virus infection (DENV-1) with (probably) persisting anti-Dengue-IgM,

accepted clinical interpretation: recent / past infection

traveller returned from Sri Lanka,

blood collected 11 months after onset of disease

anti-Dengue-IgG

anti-Dengue-IgM

Dengue NS1-Ag

350055

positive positive negative

sample 350055 and sample 350054 derive from the same patient D25

sample 350055 is a primarily derived serum

from patient D25

pool of sera from one and the same patient D25 with a recent primary dengue virus

infection (DENV-1),

traveller returned from Sri Lanka,

blood collected 2, 5 and 6 weeks after onset of disease

anti-Dengue-IgG anti-Dengue-IgM Dengue NS1-Ag

350056

negative negative positive

dengue virus serum D24 represents an acute primary

dengue virus infection positive for NS1-Ag only: serum of a healthy blood donor without signs of an acute or past dengue virus infection spiked with a cell culture propagated virus (DENV-2; heat inactivated)

anti-Dengue-IgG

anti-Dengue-IgM

Dengue NS1-Ag

350057

negative negative negative

serum of a healthy blood donor without signs of an acute, recent or past dengue virus infection

Non-marked samples derive from independent preparations.

* The EQA program Virus Immunology - Dengue Viruses (350) is performed in cooperation with Bernhard-Nocht-Institut, Hamburg (Nationales Referenzzentrum für tropische Infektionserreger und WHO Collaborating Centre for Arbovirus and Haemorrhagic Fever Reference and Research; Prof. Dr. Stephan Günther, Dr. Petra Emmerich and Prof. Dr. Dr. Jonas Schmidt-Chanasit).

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Table 3 (contd.): EQA Schemes Virus Immunology - March 2017 Pre-evaluation

Program Group RiliBÄK Analyte Sample Sample properties

qualitative dilution sample source

Hanta-viruses*

(Ab)

serum

355*

conform to

B 2

anti-Puumala-IgG anti-Puumala-IgM

355053 positive positive

serum from patient H24 with an acute Puumala virus infection acquired in northern Lower Saxony, Germany,

anamnesis concerning a stay abroad outside Europe excluded

at onset of disease hospitalization necessary, characteristic flu-like symptoms with fever and abnormal fatigue

blood collected approx. 5 weeks after onset of disease (serum is negative for Hantavirus RNA)

anti-Hanta-IgG anti-Hanta-IgM

355054 negative negative

serum of healthy blood donors (pool) without signs of an acute

or past hanta virus infection

anti-Dobrava-IgG anti-Dobrava-IgM

355055 positive negative

serum from patient H13 with a past Dobrava-Belgrade virus infection, probably acquired in Brandenburg, Germany, anamnesis concerning a stay abroad outside Europe excluded

at onset of disease hospitalization necessary, characteristic symptoms such as elevated creatinine, flu-like symptoms and abnormal fatigue

blood collected approx. 5 years after onset of disease

anti-Dobrava-IgG anti-Dobrava-IgM

355056 positive negative

serum from patient H13 with a past Dobrava-Belgrade virus infection

for anamnestic details please see sample 355055

blood collected approx. 3.5 years after onset of disease

Non-marked samples derive from independent preparations. * The EQA program Virus Immunology - Hantaviruses (355) is performed in cooperation with Nationales Konsiliarlaboratorium für

Hantaviren (Charité - Universitätsmedizin Berlin, Campus Mitte, Institut für Medizinische Virologie, Labor Berlin-Charité Vivantes GmbH, Prof. Dr. Jörg Hofmann).

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Table 3 (contd.): EQA Schemes Virus Immunology - March 2017 Pre-evaluation

Program Group RiliBÄK Analyte Sample Sample properties

qualitative dilution sample source

Hepatitis A virus (Ab)

serum

343

manda-tory:

B 2

anti-HAV 343109 negative 0 -19 mlU/ml (6 mIU/ml target value)

negative healthy blood donors (pool)

anti-HAV 343110 positive ≥ 60 mIU/ml (60 mIU/ml)*

1 : 380 anti-HAV-IgG positive healthy blood donor

anti-HAV-IgM 343111 negative negative healthy blood donors (pool)

anti-HAV-IgM 343112 positive 1 : 10 acute hepatitis A

Hepatitis B virus

(prog. 1)

(HBsAg anti-HBs anti-HBc)

serum

344

manda-tory:

B 3

HBsAg 344325 negative 0.00 – 0.07 IU/ml (0.00 IU/ml target value)

negative healthy blood donors (pool)

HBsAg 344326 positive 4.50 – 12.00 IU/ml (6.59 IU/ml target value)

(a) 1 : 600

chronic hepatitis B HBsAg 344327 positive 1.50 – 4.00 IU/ml (2.24 IU/ml target value)

(a) 1 : 1 800

HBsAg 344328 positive 13.50 – 36.00 IU/ml (18.97 IU/ml target value)

(a) 1 : 200

manda-tory:

B 2

anti-HBs 344329 positive 100 – 320 IU/l (215 IU/l target value)

(b) 1 : 150 anti-HBs positive healthy blood donor

anti-HBs 344330 negative 0 – 9 IU/l (0 IU/l target value)

negative healthy blood donors (pool)

anti-HBs 344331 positive 25 – 80 IU/l (51 IU/l target value)

(b) 1 : 600

anti-HBs positive healthy blood donor

anti-HBs 344332 positive 50 – 160 IU/l (101 IU/l target value)

(b) 1 : 300

manda-tory:

B 2

anti-HBc 344333 negative negative healthy blood donors (pool)

anti-HBc 344334 positive (c) 1 : 800 chronic hepatitis B (negative for HBeAg, anti-HBc-IgM negative)

anti-HBc 344335 positive (c) 1 : 1 600

anti-HBc 344336 positive (c) 1 : 400

a, b, c: Marked samples derive from corresponding stock materials diluted in consecutive steps.

Non-marked samples derive from independent preparations.

* For highly concentrated samples some commercial tests for the detection of anti-HAV-IgG or anti-HAV-total reveal values > 60 mIU/ml, which are outside the linear measurement range of the respective test system. Therefore a final target value derived from a consensus value from all results stated in mIU/ml could not be assigned to highly concentrated samples. In this case a lower limit value in mIU/ml is indicated in order to assess a reported result of a laboratory as a "correct" result.

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Table 3 (contd.): EQA Schemes Virus Immunology - March 2017 Pre-evaluation

Program Group RiliBÄK Analyte Sample Sample properties

qualitative dilution sample source

Hepatitis B virus

(prog. 2)

(anti-HBc-IgM HBeAg

anti-HBe)

serum

345

manda-tory:

B 2

anti-HBc-IgM 345163 positive 1 : 60 acute hepatitis B

anti-HBc-IgM 345164 negative negative healthy blood donors (pool)

manda-tory:

B 3

HBeAg 345165 positive 1 : 750 chronic hepatitis B

HBeAg 345166 negative negative healthy blood donors (pool)

manda-tory:

B 2

anti-HBe 345167 positive 1 : 90 chronic hepatitis B (negative for HBeAg)

anti-HBe 345168 negative negative healthy blood donors (pool)

Hepatitis C virus

(Ab and

HCV-Ag)

serum*

plasma**

346

anti-HCV

manda-tory:

B 2 HCV Ag

manda-tory:

B 3

anti-HCV HCV antigen

346109** positive positive

(d) 1 : 60 chronic hepatitis C (subtype 1b)

anti-HCV HCV antigen

346110* positive negative

1 : 15 condition after chronic hepatitis C (subtype 1b) (successful therapy)

anti-HCV HCV antigen

346111** positive positive

(d) 1 : 30 chronic hepatitis C (subtype 1b)

anti-HCV HCV antigen

346112* negative negative

negative healthy blood donors (pool)

HIV-1/ HIV-2 (Ab)

serum

335

manda-tory:

B 2

anti-HIV-1 335109 positive (e) 1 : 120

HIV-1 infection anti-HIV-1 335110 positive (e) 1 : 240

anti-HIV-1 335111 positive (e) 1 : 60

anti-HIV-1/2 335112 negative negative healthy blood donors (pool)

HIV-1 p24 Ag

serum

337

manda-tory:

B 3

p24 Ag 337055 negative negative healthy blood donors (pool)

p24 Ag 337056 positive 1 : 16 250

HIV-1 infection (spiked serum pool of negative blood donors; HIV-1 heat inactivated)

d, e: Marked samples derive from corresponding stock materials diluted in consecutive steps.

Non-marked samples derive from independent preparations.

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Table 3 (contd.): EQA Schemes Virus Immunology - March 2017 Pre-evaluation

Program Group RiliBÄK Analyte Sample Sample properties

qualitative dilution sample source

Zika virus* (Ab)

serum

338*

conform to

B 2

anti-Zika-IgG anti-Zika-IgM

338007 negative negative

negative healthy blood donor

anti-Zika-IgG anti-Zika-IgM

338008

positive negative The results for anti-Zika-IgM obtained by a test of one manufacturer (EuroImmun, Arbovirus-Fever-Mosaic 2) were inconsistent and have not been evaluated (without disadvantage for the certificate).

serum of patient Z3 with a past Zika virus infection

stay in South America (Columbia, Peru, Chile, Bolivia and Argentina)

clinical signs: fever, headache, muscle pain, joint pain and rash

blood collected: approx. 4 months after onset of disease

anti-Zika-IgG anti-Zika-IgM

338009 positive positive/borderline

sera of patient Z4 with a post-acute Zika virus infection (Zika virus RNA not detectable anymore)

stay in the Caribbean / Martinique

clinical signs: diarrhea, night sweats, exanthema, swelling of the joints, conjunctivitis

blood collected: 2.5 and 5 weeks after onset of disease

Non-marked samples derive from independent preparations. * The EQA program Virus Immunology - Zika Virus (338) is performed in cooperation with Bernhard-Nocht-Institut, Hamburg

(Nationales Referenzzentrum für tropische Infektionserreger und WHO Collaborating Centre for Arbovirus and Haemorrhagic Fever Reference and Research; Prof. Dr. Stephan Günther, Dr. Petra Emmerich and Prof. Dr. Dr. Jonas Schmidt-Chanasit).

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EQA Schemes Virus Genome Detection by PCR/NAT

March 2017

Pre-evaluation

Notices

Evaluation of results for quantitative genome detection of CMV

1 Notice for German and foreign participants of EQA scheme 365: For evaluation, "IU/ml" have primarily been considered as measurement units of the quantitative results for the analyte CMV. This is in accordance to the "Guideline of the German Medical Association (Bundesärztekammer / RiliBÄK)", Specified RiliBÄK Section B 3, Table B. 3-2a,

When applying CE-marked tests, which not (yet) allow reporting of results in IU/ml, it should be continued to report the results as stated by the manufacturer.

Evaluation of results for quantitative genome detection of HBV and HCV

2 Notice for German participants of EQA schemes 361 and 362: For evaluation, "IU/ml" have been considered as measurement units of the quantitative results for the analytes HBV and HCV. This is in accordance to the "Guideline of the German Medical Association (Bundesärztekammer / RiliBÄK)", Specified RiliBÄK Section B 3, Table B. 3-2a. Statements in "copies/ml" will not be accepted anymore.

3 Notice for foreign participants of EQA schemes 361 and 362: Please note that quantitative results in "copies/ml" for the genome detection of HBV and HCV, respectively, have not been evaluated due to the low number of analyses or missing analyses.

Evaluation of results for quantitative genome detection of HIV-1 (RNA)

4 Notice for German participants of EQA scheme 360: For evaluation, "copies/ml" have been considered as measurement unit of the quantitative results for the analyte HIV-1 (RNA). This is in accordance to the "Guideline of the German Medical Association (Bundesärztekammer / RiliBÄK)", Specified RiliBÄK Section B 3, Table B. 3-2a. Statements in "IU/ml" will not be accepted anymore.

5 Notice for foreign participants of EQA scheme 360: Please note that quantitative results in "IU/ml" for the genome detection of HIV-1 (RNA) have not been evaluated due to the low number of analyses or missing analyses.

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Table 4: EQA Schemes Virus Genome Detection - March 2017

Pre-evaluation

Program Group RiliBÄK Sample

Sample properties

qualitative (note on

geno-/subtype) dilution

Target value of all methods (provisional data)

copies/ml IU/ml

BK virus (DNA)

suspension of urine

364

conform to

B 3

364025 negative 1 : 100 0.0 not evaluated# 364026 positive (a) 1 : 500 632 262.6 not evaluated#

364027 positive (a) 1 : 50 000 7 031.4 not evaluated#

364028 positive (a) 1 : 5 000 66 104.6 not evaluated#

Chikungunya virus* (RNA)

cell lysates

392*

conform to

B 3

392017 positive 1 : 1 000

Quantitative results were not reported

-----

392018 negative ------- -----

392019 positive (b) 1 : 1 000 -----

392020 positive (b) 1 : 10 000 -----

CMV (DNA)

plasma

365

manda-tory:

B 3

For evaluation of results

in copies/ml or IU/ml: see notice 1, page 11

365109 positive (c, d) 1 : 3 162 8 742.2 14 429.8

365110 positive (c) 1 : 100 300 282.7 411 438.5

365111 positive (c) 1 : 1 000 28 854.2 43 734.7

365112 positive (c) 1 : 316 88 150.9 130 106.8

CMV (DNA)

training progr.

plasma

368

conform to

B 3

368021 positive (c, d) 1 : 3 162 12 196.1 16 106.1

368022 positive (c) 1 : 100 000 523.0 414.8

368023 positive (c) 1 : 10 000 3 479.1 4 697.2

368024 positive (c) 1 : 31 628 1 080.5 1 232.8

HAV (RNA)

spiked plasma

377

manda-tory:

B 3

377109 positive (e) 1 : 1 000 not evaluated# not evaluated# 377110 negative ------- not evaluated# not evaluated#

377111 positive (e) 1 : 2 000 not evaluated# not evaluated#

377112 positive (e) 1 : 16 000 not evaluated# not evaluated#

HBV (DNA)

plasma

361

manda-tory:

B 3

361109 positive (f) 1 : 10 000 Results in copies/ml:

not accepted or

not evaluated (see notices 2 and 3,

page 11)

4 438.0

361110 positive (f) 1 : 2 000 21 878.1

361111 positive (f, g) 1 : 50 000 893.3

361112 negative ------- 0.0

HBV (DNA)

training progr.

plasma

378

conform to

B 3

378021 positive (f, g) 1 : 50 000 Results in copies/ml:

not accepted or

not evaluated (see notices 2 and 3,

page 11)

829.0

378022 not evaluated§ (f) 1 : 6 250 000 not evaluated§

378023 positive (f) 1 : 250 000 179.8

378024 positive (f) 1 : 1 250 000 43.4

# The quantitative results are not evaluated due to the low number of analysis (without disadvantage for the certificates).

§ All qualitative and quantitative results for sample 378022 with the lowest HBV genome concentration (1 : 6 250 000 diluted) were not evaluated (without disadvantage for the certificate of successful participation).

a, b, c, e, f: Marked samples derive from corresponding stock materials diluted in consecutive steps.

Non-marked samples derive from independent preparations. .

d, g: Marked samples represent overlapping samples deployed in the respective main EQA scheme (mandatory according to RiliBÄK Section B 3) and the corresponding training program.

* The EQA program Virus Genome Detection - Chikungunya Virus (392) is performed in cooperation with Bernhard-Nocht-Institut, Hamburg (Nationales Referenzzentrum für tropische Infektionserreger und WHO Collaborating Centre for Arbovirus and Haemorrhagic Fever Reference and Research; Prof. Dr. Stephan Günther, Prof. Dr. Dr. Jonas Schmidt-Chanasit and Dr. Petra Emmerich).

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Table 4 (contd.): EQA Schemes Virus Genome Detection - March 2017 Pre-evaluation

Program Group RiliBÄK Sample

Sample properties

qualitative (note on

geno-/subtype) dilution

Target value of all methods (provisional data)

copies/ml IU/ml

HCV (RNA)

plasma

362

manda-tory:

B 3

362109 positive (subtype 4a) (h) 1 : 400 Results in copies/ml:

not accepted or

not evaluated (see notices 2 and 3,

page 11)

2 417.7

362110 positive (subtype 4a) (h) 1 : 127 7 360.2

362111 positive (subtype 4a) (h) 1 : 40 21 553.7

362112 positive (subtype 4a) (h, i) 1 : 1 265 818.4

HCV (RNA)

training progr.

plasma

379

conform to

B 3

379021 positive (subtype 4a) (h) 1 : 12 650 Results in copies/ml:

not accepted or

not evaluated (see notices 2 and 3,

page 11)

100.0

379022 positive (subtype 4a) (h, i) 1 : 1 265 825.7

379023 positive (subtype 4a) (h) 1 : 40 000 33.2

379024 positive (subtype 4a) (h) 1 : 4 000 286.2

HDV (RNA)

plasma

400

conform to

B 3

400017 negative ------- not evaluated# not evaluated#

400018 positive (j) 1 : 40 not evaluated# not evaluated#

400019 positive (j) 1 : 1 000 not evaluated# not evaluated#

400020 positive (j) 1 : 200 not evaluated# not evaluated#

HIV-1 (RNA)

spiked plasma

360

manda-tory:

B 3

360109 positive (group M/

subtype B) (k) 1 : 160 000 121 961.6

Results in IU/ml: not accepted

or not evaluated (see notices 4

and 5, page 11)

360110 positive (group M/

subtype B) (k, l) 1 : 16 000 000 1 475.0

360111 negative

------- 0.0

360112 positive (group M/

subtype B) (k) 1 : 1 600 000 13 979.0

HIV-1 (RNA)

training progr.

spiked plasma

382

conform to

B 3

382021 positive (group M/

subtype B) (k, l) 1 : 16 000 000 1 334.6

Results in IU/ml: not accepted

or not evaluated (see notices 4

and 5, page 11)

382022 positive (group M/

subtype B) (k) 1 : 505 964 426 52.9

382023 positive (group M/

subtype B) (k) 1 : 160 000 000 160.2

382024 not evaluated$ (k) 1 : 1 600 000 000 not evaluated$

JC virus (DNA)

suspension of urine

394

conform to

B 3

394017 positive 1 : 50 10 159.6 -----

394018 positive 1 : 600 18 578.3 -----

394019 positive 1 : 500 30 528.8 -----

394020 negative 1 : 1 000 0.0 -----

Parvovirus B19

(DNA)

plasma

367

manda-tory:

B 3

367109 negative ------- 0.0 0.0

367110 positive (m) 1 : 40 000 94 022.5 95 840.3

367111 positive (m) 1 : 2 560 000 2 805.7 2 260.3

367112 positive (m) 1 : 160 000 29 899.4 26 689.4

# The quantitative results are not evaluated due to the low number of analysis (without disadvantage for the certificates).

$ All qualitative and quantitative results for sample 382024 with the lowest HIV-1 genome concentration (1 : 1 600 000 000 diluted) were not evaluated (without disadvantage for the certificate of successful participation).

h, j, k, m: Marked samples derive from corresponding stock materials diluted in consecutive steps.

Non-marked samples derive from independent preparations.

i, l: Marked samples represent overlapping samples deployed in the respective main EQA scheme (mandatory according to RiliBÄK Section B 3 and the corresponding training program.

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Pre-evaluation Virology March 2017 20170512.doc 14 of 15

Table 5: EQA Schemes Virus Genome Detection incl. Typing

March 2017 - Pre-evaluation

Program Group RiliBÄK Sample

Sample properties

qualitative Target value of all

methods copies/ml

species type (note on dilution)

Dengue viruses& (RNA)

cell lysates

369&

conform to

B 3

369025 positive

Quantitative results were not reported

---- DENV-1 (inactivated) 1 : 140 diluted

369026 negative ---- ---

369027 positive ---- DENV-2 (inactivated) 1 : 40 diluted

369028 positive ---- DENV-4 (inactivated) 1 : 7.5 diluted

Norovirus (RNA)

suspension of feces

381

conform to

B 3

The EQA scheme (381) were postponed to the 2nd quarter of 2017 to consider the current epidemiological situation (shipment date: 08 May 2017).

Para- influenza-

viruses (RNA)

cell lysate

388

conform to

B 3

388025 positive not evaluated# ---- PIV-2 1 : 10 000 diluted (n)

388026 positive not evaluated# ---- PIV-3 1 : 1 000 diluted (o)

388027 positive not evaluated# ---- PIV-2 1 : 100 diluted (n)

388028 positive not evaluated# ---- PIV-3 1 : 100 000 diluted (o)

West Nile virus& (RNA)

cell lysate

391&

conform to

B 3

391035 positive

Quantitative results were not reported

---- WNV-1 (inactivated) 1 : 3 000 diluted

391036 positive ---- WNV-2 (inactivated) 1 : 30 000 diluted (p)

391037 negative ---- ----

391038 positive ---- WNV-2 (inactivated) 1 : 300 diluted (p)

391039 positive ---- WNV-1 (inactivated) 1 : 30 diluted (q)

391040 positive ---- WNV-1 (inactivated) 1 : 3 diluted (q)

Zika virus& (RNA)

cell lysate*

plasma**

403&

conform to

B 3

403009* positive not evaluated# ---- African lineage (inactivated) 1 : 40 diluted (r)

403010** positive not evaluated# ---- Asian lineage (inactivated) 1 : 50 diluted (s)

403011** positive not evaluated# ---- Asian lineage (inactivated) 1 : 500 diluted (s)

403012* positive not evaluated# ---- African lineage (inactivated) 1 : 4 000 diluted (r)

# The quantitative results are not evaluated due to the low number of analysis (without disadvantage for the certificates).

n, o, p, q, r, s: Marked samples derive from corresponding stock materials diluted in consecutive steps.

Non-marked samples derive from independent preparations.

& The EQA programs Virus Genome Detection - Dengue Viruses (369), West Nile Virus (391) and Zika Virus (403) are performed in cooperation with Bernhard-Nocht-Institut, Hamburg (Nationales Referenzzentrum für tropische Infektionserreger und WHO Collaborating Centre for Arbovirus and Haemorrhagic Fever Reference and Research; Prof. Dr. Stephan Günther, Prof. Dr. Dr. Jonas Schmidt-Chanasit and Dr. Petra Emmerich).

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Pre-evaluation Virology March 2017 20170512.doc 15 of 15

Table 5 (contd.): EQA Schemes Virus Genome Detection incl. Typing March 2017 - Pre-evaluation

Program Group RiliBÄK Sample Sample properties and results considered as "correct" (target values)

type/subtype strain origin

Influenza A-und B-viruses*

inclusive

influenza A(H1N1)

pdm09 virus

and

avian influenza A

virus (different subtypes)

(genome/ antigen)

370*

manda-tory:

B 3

The EQA scheme (370) were postponed to the 2nd quarter of 2017 to consider the current epidemiological situation (shipment date: 08 May 2017).

* The EQA program for influenza A and B viruses, incl. influenza A(H1N1) pdm09 virus and avian influenza A virus (different subtypes), is performed in cooperation with Nationales Referenzzentrum für Influenza, Robert Koch-Institut, Berlin, Dr. Brunhilde Schweiger and Dr. Barbara Biere and Nationales Referenzlabor für Aviäre Influenza, Bundesforschungsinstitut für Tiergesundheit, Friedrich-Loeffler-Institut, Insel Riems, Prof. Dr. Timm C. Harder.